Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
Information source: Somerset Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mental Health; Major Depressive Disorder
Intervention: Selegiline Trandermal System (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Somerset Pharmaceuticals Official(s) and/or principal investigator(s):
Thomas Hochadel, Pharm.D., Study Director, Affiliation: Cognitive Research Corporation
Melissa L Goodhead, Study Chair, Affiliation: Somerset Pharmaceuticals
Overall contact:
Thomas Hochadel, Pharm.D., Phone: 727-897-9000, Email: thochadel@cogres.com
Summary
The primary purpose of your participation in this study is to help answer the following
research question: Whether 12-week administration of EMSAM (selegiline transdermal system)
is safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major
Depressive Disorder.
Clinical Details
Official title: A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible Dose Study of the Safety and Efficacy of EMSAM in Adolescents With Major Depression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for MDD without psychotic features, single or recurrent
Detailed description:
• Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in
adolescents (aged 12 through 17 years) who meet criteria for MDD without psychotic features,
single or recurrent
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male / Female outpatients 12 to 17 years of age diagnosed with MDD. (Must have a
CDRS-R with a total score of at least 45 at screening.
- Female patients must test negative on a pregnancy at visit 1.
- Weight and height must be greater than the 10th percentile according to age and
height,
- Assent and consent must be given.
Exclusion Criteria:
- Have a serious or unstable medical illness, psychological condition, clinically
significant laboratory or ECG result, hypersensitivity to selegiline, or any other
condition that in the opinion of the investigator would compromise participation in
the study or be likely to lead to hospitalization during the course of the study.
- Have a current or previous diagnosis of bipolar disorder, psychotic depression,
schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive
disorder, pervasive development disorder or borderline personality disorder, as
determined by the investigator.
- Have a risk of suicide
- Female patients who are either pregnant, nursing or have recently given birth.
- Use of any protocol prohibited medications or substances.
Locations and Contacts
Thomas Hochadel, Pharm.D., Phone: 727-897-9000, Email: thochadel@cogres.com
Dr. Nelson Handal, Dothan, Alabama, United States; Recruiting
Nelson Handal, MD, Phone: 334-836-2000
Dr. Mohammed Bari, National City, California, United States; Recruiting
Mohammed Bari, MD, Phone: 888-619-7272
Dr. Michael McManus, SanDiego, California, United States; Recruiting
Michael McManus, MD, Phone: 858-505-8029
Dr. Elias Sarkis, Gainesville, Florida, United States; Recruiting
Elias Sarkis, MD, Phone: 352-333-0094
Dr. Scott Segal, North Miami, Florida, United States; Recruiting
Scott Segal, MD, Phone: 877-734-2589
Dr. Mary Stedman, Tampa, Florida, United States; Recruiting
Mary Stedman, MD, Phone: 813-971-8311
Dr. Irving Kolin, Winter Park, Florida, United States; Recruiting
Irving Kolin, MD, Phone: 407-644-1122
Dr. Rory Murphy, Overland Park, Kansas, United States; Recruiting
Rory Murphy, MD, Phone: 913-484-4046
Dr. Andrew Sediloo, Owensboro, Kentucky, United States; Recruiting
Andrew Sediloo, MD, Phone: 270-685-4589
Dr. Bruce Waslick, Springfield, Massachusetts, United States; Recruiting
Bruce Waslick, MD, Phone: 413-794-1136
Dr. Christopher Kratochvil, Omaha, Nebraska, United States; Recruiting
Christopher Kratochvil, MD, Phone: 402-552-6005
Dr. Ann Childress, Las Vegas, Nevada, United States; Recruiting
Ann Childress, MD, Phone: 702-838-0742
Dr. Melissa DelBello, Cincinnati, Ohio, United States; Recruiting
Melissa DelBello, MD, Phone: 513-558-4112
Dr. Leland Dennis, Oklahoma City, Oklahoma, United States; Recruiting
Leland Dennis, MD, Phone: 405-603-8068
Dr. David Brown, Austin, Texas, United States; Recruiting
David Brown, MD, Phone: 866-798-2622
Dr. Alain Katic, Bellaire, Texas, United States; Recruiting
Alain Katic, MD, Phone: 713-665-6446
Dr. Graham Emslie, Dallas, Texas, United States; Recruiting
Graham Emslie, MD, Phone: 214-456-5900
Dr. Mary Shemo, Charlottesville, Virginia, United States; Recruiting
Mary Shemo, MD, Phone: 434-984-0005
Dr. John Gilliam, Richmond, Virginia, United States; Recruiting
John Gilliam, MD, Phone: 804-270-6811
Dr. Arifulla Khan, Bellevue, Washington, United States; Recruiting
Arifulla Khan, MD, Phone: 877-453-0404
Additional Information
Starting date: July 2007
Last updated: April 21, 2008
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